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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-06-24 to 1999-11-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4,6,10-Dodecatetraen-3-ol,3,7,11-trimethyl-,(4E,6E)-
EC Number:
611-799-6
Cas Number:
59121-99-2
Molecular formula:
C15H24O
IUPAC Name:
1,4,6,10-Dodecatetraen-3-ol,3,7,11-trimethyl-,(4E,6E)-
Test material form:
liquid: viscous

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 2.41 - 2.70 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area : 3000 cm2. No bedding in the cages; wood shavings in the waste trays.
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: For at least 1 week .

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully air-conditioned rooms.
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6 .00 a.m. - 6 .00 p.m./6 .00 p.m . - 6 .00 a .m.)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL (unchanged)
Duration of treatment / exposure:
single dose for 24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
1 female
2 males
Details on study design:
- Application: The test substance was applied in a single dose to the conjunctival sac of the right eyelid. Both eyes of the animal(s) were examined before application of the test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study.
- Readings: 1 h, 24 h, 48 h, 72 h and 7 d after application.
- Mortality: A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays and on public holidays.

REMOVAL OF TEST SUBSTANCE
- Washing: the substance was washed out with tap water about 24 hours after application (before 24 hour reading).
- Time after start of exposure: 24 hours

SCORING SYSTEM: as specified in OECD 405 (1987) and EEC directive 92/69, L 383A, B.5 (1992)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 h - 48 h - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
One of three animals showed small retractions in the eyelid (24 h - 72 h). Loss of corneal tissue was observed for two of three animals (48 h - 72 h), aswell as discharge of blood and suppuration occured for one animal after 48 h. All symptons were reversible within 7 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU